Therapy
| Induction (1 mo) | |
| Regimens OP and IP | Oral prednisone (40 mg/m2/d), IV vincristine (1.5 mg/m2 on days 0, 7, 14, and 21), intramuscular native L-asparaginase (6000 U/m2, 3 times weekly for 9 doses, starting on days 2-4),and age-adjusted intrathecal methotrexate (age 1 to less than 2 years, 8 mg; age 2 to less than 3 years, 10 mg; older than 3 years, 12 mg on days 0 and 14). Patients with CNS disease at diagnosis also received intrathecal methotrexate on days 7 and 21. |
| Regimens OD and ID | Oral dexamethasone (6 mg/m2/day in 3 equal doses) was substituted for prednisone. |
| Consolidation (3 mo) | |
| Regimen OP | Oral mercaptopurine (75 mg/m2/d on days 0-70), oral prednisone (40 mg/m2 on days 28-32 and 56-60), IV vincristine (1.5 mg/m2 on days 0, 28, and 56), oral methotrexate (20 mg/m2 on days 28, 35, 42, 49, 56, 63, and 70), and age-adjusted (see above) intrathecal methotrexate on days 0, 7, 14, and 21 for patients without CNS disease at diagnosis and on days 0 and 7 for patients with CNS disease at diagnosis. |
| Regimen IP | Modification of Regimen OP, substituting IV mercaptopurine (1000 mg/m2 over 10 hours on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, and 70) for oral. |
| Regimen OD | Modification of Regimen OP, substituting dexamethasone (6 mg/m2/day on days 28-32 and 56-60) for prednisone. |
| Regimen ID | Modification of Regimen OP, substituting IV mercaptopurine for oral as in Regimen IP and dexamethasone for prednisone as in Regimen OD. |
| Delayed intensification (2 mo) | Oral dexamethasone in all patients (10 mg/m2/d for 21 days plus a 7-day taper), IV vincristine (1.5 mg/m2 on days 0, 7, and 14), intramuscular native L-asparaginase (6000 U/m2 for 6 doses given M/W/F on days 3-17), doxorubicin (25 mg/m2, IV push, on days 0, 7, and 14), IV cyclophosphamide (1000 mg/m2 over 30 minutes on day 28), oral 6-thioguanine (60 mg/m2/day on days 28-41), cytarabine (75 mg/m2/day, IV push, on days 29-32 and 36-39), and age-adjusted intrathecal methotrexate on day 28. |
| Maintenance (girls, 20 mo; boys, 32 mo) | |
| Regimen OP and IP | Oral prednisone (40 mg/m2 on days 0-4, 28-32, and 56-60), oral mercaptopurine in all patients (75 mg/m2/day on days 0-83), IV vincristine (1.5 mg/m2 on days 0, 28, and 56),weekly oral methotrexate (20 mg/m2 beginning on day 7 of each course), and age-adjusted intrathecal methotrexate (see above) on day 0 of each course. |
| Regimen OD and ID | Dexamethasone (6 mg/m2/d on days 0-4, 28-32, and 56-60) was substituted for prednisone. |
| Induction (1 mo) | |
| Regimens OP and IP | Oral prednisone (40 mg/m2/d), IV vincristine (1.5 mg/m2 on days 0, 7, 14, and 21), intramuscular native L-asparaginase (6000 U/m2, 3 times weekly for 9 doses, starting on days 2-4),and age-adjusted intrathecal methotrexate (age 1 to less than 2 years, 8 mg; age 2 to less than 3 years, 10 mg; older than 3 years, 12 mg on days 0 and 14). Patients with CNS disease at diagnosis also received intrathecal methotrexate on days 7 and 21. |
| Regimens OD and ID | Oral dexamethasone (6 mg/m2/day in 3 equal doses) was substituted for prednisone. |
| Consolidation (3 mo) | |
| Regimen OP | Oral mercaptopurine (75 mg/m2/d on days 0-70), oral prednisone (40 mg/m2 on days 28-32 and 56-60), IV vincristine (1.5 mg/m2 on days 0, 28, and 56), oral methotrexate (20 mg/m2 on days 28, 35, 42, 49, 56, 63, and 70), and age-adjusted (see above) intrathecal methotrexate on days 0, 7, 14, and 21 for patients without CNS disease at diagnosis and on days 0 and 7 for patients with CNS disease at diagnosis. |
| Regimen IP | Modification of Regimen OP, substituting IV mercaptopurine (1000 mg/m2 over 10 hours on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, and 70) for oral. |
| Regimen OD | Modification of Regimen OP, substituting dexamethasone (6 mg/m2/day on days 28-32 and 56-60) for prednisone. |
| Regimen ID | Modification of Regimen OP, substituting IV mercaptopurine for oral as in Regimen IP and dexamethasone for prednisone as in Regimen OD. |
| Delayed intensification (2 mo) | Oral dexamethasone in all patients (10 mg/m2/d for 21 days plus a 7-day taper), IV vincristine (1.5 mg/m2 on days 0, 7, and 14), intramuscular native L-asparaginase (6000 U/m2 for 6 doses given M/W/F on days 3-17), doxorubicin (25 mg/m2, IV push, on days 0, 7, and 14), IV cyclophosphamide (1000 mg/m2 over 30 minutes on day 28), oral 6-thioguanine (60 mg/m2/day on days 28-41), cytarabine (75 mg/m2/day, IV push, on days 29-32 and 36-39), and age-adjusted intrathecal methotrexate on day 28. |
| Maintenance (girls, 20 mo; boys, 32 mo) | |
| Regimen OP and IP | Oral prednisone (40 mg/m2 on days 0-4, 28-32, and 56-60), oral mercaptopurine in all patients (75 mg/m2/day on days 0-83), IV vincristine (1.5 mg/m2 on days 0, 28, and 56),weekly oral methotrexate (20 mg/m2 beginning on day 7 of each course), and age-adjusted intrathecal methotrexate (see above) on day 0 of each course. |
| Regimen OD and ID | Dexamethasone (6 mg/m2/d on days 0-4, 28-32, and 56-60) was substituted for prednisone. |